Submission for OMB Review; 30-Day Comment Request Investigational Agent Accountability Record Forms and International Investigator Statement in the Conduct of Investigational Trials for the Treatment of Cancer (National Cancer Institute), 67067-67068 [2021-25605]
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Federal Register / Vol. 86, No. 224 / Wednesday, November 24, 2021 / Notices
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: June 29, 2012. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
June 29, 2012.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): May 18, 2018. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
TRODELVY (BLA 761115) was initially
submitted on May 18, 2018.
3. The date the application was
approved: April 22, 2020. FDA has
verified the applicant’s claim that BLA
761115 was approved on April 22, 2020.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,780 days of patent
term extension.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
VerDate Sep<11>2014
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Dated: November 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–25612 Filed 11–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Delegation of Authority
Notice is hereby given that I have
withdrawn the delegations to the
Director, Office for Civil Rights (OCR),
or their successor, with respect to the
Religious Freedom Restoration Act
(RFRA) and the Religion Clauses of the
First Amendment, as well as any other
delegation of authority to OCR with
respect to enforcing or complying with
RFRA or the First Amendment.
On December 7, 2017, the then-Acting
Secretary of the Department of Health
and Human Services issued a notice,
published on January 19, 2018 (83 FR
2804), that delegated authority for
implementation and compliance with
the Religious Freedom Restoration Act,
42 U.S.C. 2000bb et seq., within the
Department to the Director of OCR.
On January 15, 2021, the Secretary
further delegated to OCR authority to
receive and investigate complaints,
conduct compliance reviews, provide
technical assistance and training,
evaluate complaint processing and
provide reports, and ensure uniform
compliance with the Religion Clauses of
the First Amendment. This delegation
was not published in the Federal
Register.
The Department takes its obligations
to comply with RFRA and the First
Amendment seriously, and it will
continue to do so. Department
components have the greatest
knowledge about their respective
programs and are best able to determine
whether the Department has a
compelling interest in a particular
action and whether less restrictive
means are available to further that
interest, critical aspects of the legal test
under RFRA. Furthermore, under the
current Statement of Organization,
Functions, and Delegations of Authority
for the Office of General Counsel (OGC),
OGC provides legal advice to the
Secretary, Deputy Secretary, and all
subordinate organization components of
the Department. See 85 FR 47228 (July
7, 2020). Department components, in
consultation with OGC, have the
responsibility, and are best positioned,
to evaluate RFRA-based requests for
exemptions, waivers, and modifications
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67067
of program requirements in the
programs they operate or oversee.
Department components, further, are
best situated to craft exemptions or
other modifications when required
under RFRA and to monitor the impact
of such exemptions or modifications on
programs and those they serve.
Moreover, they are best positioned to
evaluate how their programs must be
run to comply with the Free Exercise
Clause and the Establishment Clause of
the First Amendment.
I therefore rescind the December 7,
2017, and the January 15, 2021
delegations with respect to the Religion
Clauses of the First Amendment and/or
RFRA, as well as any other delegation
of authority to OCR with respect to
enforcing or complying with RFRA or
the First Amendment. Effective today, I
delegate responsibility to Department
components to ensure full compliance
with RFRA and other constitutional
requirements. Department components
must consult with OGC on such matters
and provide appropriate consideration
to RFRA- or Constitution-based
objections or requests, as well as take
any actions that may be appropriate.
This delegation of authority is
effective upon date of signature.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–25632 Filed 11–23–21; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Investigational
Agent Accountability Record Forms
and International Investigator
Statement in the Conduct of
Investigational Trials for the Treatment
of Cancer (National Cancer Institute)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:
E:\FR\FM\24NON1.SGM
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67068
Federal Register / Vol. 86, No. 224 / Wednesday, November 24, 2021 / Notices
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Charles Hall,
Chief, Pharmaceutical Management
Branch, Cancer Therapy Evaluation
Program, Division of Cancer Diagnosis
and Treatment, National Cancer
Institute, 9609 Medical Center Drive,
Bethesda, Maryland, 20892 or call nontoll-free number (240) 276–6575 or
email your request, including your
address to: HallCh@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on September 14, 2021 (Vol. 86
FR 51168) and allowed 60 days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
ADDRESSES:
Institute/Division of Cancer Treatment
and Diagnosis/Cancer Therapy
Evaluation Program (NCI/DCTD/CTEP)
is managed by the Pharmaceutical
Management Branch (PMB) at CTEP.
The Investigational Agent
Accountability Records (a.k.a. Drug
Accountability Record Forms—DARF)
are used to provide a standardized
method of tracking of agent disposition
across all institutions participating in
trials for which the NCI provides agent.
Institutional auditors verify information
on the agent accountability forms for
compliance. In addition, PMB staff
review Investigational Agent
Accountability Record Forms against
records maintained in PMB systems to
ensure there is no inappropriate use or
diversion of investigational agents.
Additionally, the International
Investigator Statement (IIS) will be used
by non-U.S. investigators, that are
unable to sign the FDA 1572 (OMB No.
0925–0753, Expiration 05/31/2024) to
attest compliance with applicable
country-specific regulations.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden are 4,831
hours.
Cancer Institute (NCI), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Investigational
Agent Accountability Record Forms and
International Investigator Statement in
the Conduct of Investigational Trials for
the Treatment of Cancer (National
Cancer Institute), 0925–0613, Expiration
Date 3/31/2022, REVISION, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The Food and Drug
Administration (FDA) require
Investigational New Drug Application
(IND) sponsors to maintain adequate
records on the shipment and disposition
of agents to investigators. The agent
accountability effort for National Cancer
ESTIMATED ANNUALIZED BURDEN HOURS
A1: Investigational Agent Accountability Record Form
(DARF).
A2: Investigational Agent Accountability Record for Oral
Agents Form (DARF-Oral).
A3: Electronic Agent Accountability Record Form
(eDARF).
A4: International Investigator Statement (IIS) (Initial Response).
Individuals ........
760
20
4/60
1,013
Individuals ........
2,280
20
4/60
3,040
Individuals .........
760
20
1/60
253
Individuals ........
2,100
1
15/60
525
...........................
5,900
78,100
........................
4,831
Dated: November 18, 2021.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2021–25605 Filed 11–23–21; 8:45 am]
Submission for OMB Review; 30-Day
Comment Request; The Genetic
Testing Registry (Office of the
Director)
BILLING CODE 4140–01–P
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Average
time per
response
(in hours)
Category of
respondent
Totals .........................................................................
Number of
respondents
Number of
responses per
respondent
Form name
National Institutes of Health
AGENCY:
National Institutes of Health,
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
SUMMARY:
VerDate Sep<11>2014
17:05 Nov 23, 2021
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Sfmt 4703
and Budget (OMB) a request for review
and approval of the information
collection listed below.
Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
DATES:
HHS.
ACTION:
Total annual
burden hours
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
ADDRESSES:
E:\FR\FM\24NON1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Pages 67067-67068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25605]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Investigational
Agent Accountability Record Forms and International Investigator
Statement in the Conduct of Investigational Trials for the Treatment of
Cancer (National Cancer Institute)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval of the
information collection listed below.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 30-days of the date of
this publication.
[[Page 67068]]
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Charles Hall, Chief, Pharmaceutical Management
Branch, Cancer Therapy Evaluation Program, Division of Cancer Diagnosis
and Treatment, National Cancer Institute, 9609 Medical Center Drive,
Bethesda, Maryland, 20892 or call non-toll-free number (240) 276-6575
or email your request, including your address to: [email protected].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on September 14, 2021
(Vol. 86 FR 51168) and allowed 60 days for public comment. No public
comments were received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Cancer Institute
(NCI), National Institutes of Health, may not conduct or sponsor, and
the respondent is not required to respond to, an information collection
that has been extended, revised, or implemented on or after October 1,
1995, unless it displays a currently valid OMB control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, the National Institutes of Health (NIH) has submitted to
the Office of Management and Budget (OMB) a request for review and
approval of the information collection listed below.
Proposed Collection: Investigational Agent Accountability Record
Forms and International Investigator Statement in the Conduct of
Investigational Trials for the Treatment of Cancer (National Cancer
Institute), 0925-0613, Expiration Date 3/31/2022, REVISION, National
Cancer Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Food and Drug
Administration (FDA) require Investigational New Drug Application (IND)
sponsors to maintain adequate records on the shipment and disposition
of agents to investigators. The agent accountability effort for
National Cancer Institute/Division of Cancer Treatment and Diagnosis/
Cancer Therapy Evaluation Program (NCI/DCTD/CTEP) is managed by the
Pharmaceutical Management Branch (PMB) at CTEP. The Investigational
Agent Accountability Records (a.k.a. Drug Accountability Record Forms--
DARF) are used to provide a standardized method of tracking of agent
disposition across all institutions participating in trials for which
the NCI provides agent. Institutional auditors verify information on
the agent accountability forms for compliance. In addition, PMB staff
review Investigational Agent Accountability Record Forms against
records maintained in PMB systems to ensure there is no inappropriate
use or diversion of investigational agents. Additionally, the
International Investigator Statement (IIS) will be used by non-U.S.
investigators, that are unable to sign the FDA 1572 (OMB No. 0925-0753,
Expiration 05/31/2024) to attest compliance with applicable country-
specific regulations.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden are 4,831 hours.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average time
Form name Category of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
A1: Investigational Agent Accountability Record Individuals............................ 760 20 4/60 1,013
Form (DARF).
A2: Investigational Agent Accountability Record Individuals............................ 2,280 20 4/60 3,040
for Oral Agents Form (DARF-Oral).
A3: Electronic Agent Accountability Record Form Individuals............................ 760 20 1/60 253
(eDARF).
A4: International Investigator Statement (IIS) Individuals............................ 2,100 1 15/60 525
(Initial Response).
---------------------------------------------------------------
Totals..................................... ....................................... 5,900 78,100 .............. 4,831
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: November 18, 2021.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2021-25605 Filed 11-23-21; 8:45 am]
BILLING CODE 4140-01-P
